BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3013568 · Received March 20, 2013

    Report

    Report Number
    2953200-2013-00498
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, RENAL COMPLICATIONS). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (RENAL COMPLICATIONS). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (RENAL COMPLICATIONS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THERE WAS MODERATE VESSEL TORTUOSITY AND MILD VESSEL CALCIFICATION. IT WAS REPORTED THAT THE PATIENT HAD RENAL COMPLICATIONS THE FOLLOWING DAY AFTER THE PROCEDURE. TESTS WERE DONE AND AN ULTRASOUND WAS COMPLETED WHICH SHOWED FLOW TO THE RENAL ARTERIES; HOWEVER, THE PATIENT DID NOT RECOVER AND WAS PUT ON DIALYSIS. THE PATIENT EXPIRED THREE WEEKS AFTER THE PROCEDURE. THE CAUSE OF RENAL COMPLICATIONS AND DEATH ARE UNKNOWN. THE PHYSICIAN ASSESSED THIS EVENT AS NOT DEVICE RELATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115769 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03012390

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Death